NDA is under review in the U.S.
Dainippon Sumitomo Pharma (DSP) will pay $20 million upfront for the exclusive Japanese rights to Neurocrine Biosciences’ insomnia drug, indiplon.
Neurocrine has submitted an NDA in the U.S. and expects PUDFA action on December 12. If approved, the company will receive an additional $10 million. Neurocrine is eligible to receive additional milestone fees associated with the successful development and commercialization of the indiplon immediate-release formulation in Japan.
Upon commercialization of indiplon, Neurocrine will receive royalties from DSP based on sales in Japan. DSP also has a right to develop and commercialize the modified-release formulation of indiplon in Japan, which would result in additional milestone payments and royalties to Neurocrine.
In 2006 the sedative hypnotic market in Japan was valued at approximately $500 million, according to the firms.
